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BackgroundThe prevalence of preventable non-communicable disease (NCD) underpins the need for a life-course and cross-sectoral approach to population health that is grounded in health promotion and disease prevention. European Union (EU) countries typically spend 6 to 13% of gross domestic product (GDP) on health care, yet less than 3% of this is dedicated to prevention. The extent to which spending in other sectors prevents avoidable ill-health is largely unknown. The lack of fiscal space post-COVID-19 means shifting from models of care built around treatment to those with greater emphasis on prevention will require innovative, evidence-based investment within and between sectors. The term “smart capacitating investment” (SCI) has previously been used to understand how to best boost social infrastructure investment in education, health, transport and housing across the EU. Here we take that idea further by exploring the applicability of SCI to public health financing to improve population health and well-being.AimTo explore and develop innovative SCI models and tools that enable collaboration and investment across health ecosystems for enhanced health promotion and disease prevention, test them in diverse real-world settings, and create a roadmap for large-scale implementation.MethodsThe Invest4Health (I4H) project brings together transdisciplinary expertise in epidemiology, public health, health economics, population science, business management, finance, implementation and social sciences, digital health innovation, and regional health systems. The project consists of eight work packages which span the exploration and conceptualisation of SCI in public health; the characterisation of SCI-compatible business and finance models; piloting and evaluation of these models in four European testbeds (Sweden, Germany, Spain and Wales UK); and exploring the opportunities for sustainable replication and scaling of SCI and future research.DiscussionWe present an introduction to the I4H project, the concept of SCI applied to public health, plus key points for discussion internationally.

Self-poisoning with paracetamol is the most frequently used overdose method in the UK. Psychosocial assessments were conducted by mental health clinicians with 127 consecutive individuals who presented with pure paracetamol overdoses to a large general hospital over 8 months, including asking about the source of the tablets and scoring the patients’ acts on the Beck Suicide Intent scale (BSI). Patients were predominantly female (86%) and young (79% aged 12–24 years). Most had used paracetamol which was available in the home (77%). Those who purchased paracetamol for the act took double the number of tablets compared with those who used paracetamol available in the home (37 v. 18), had higher suicidal intent (mean BSI: 11 v. 7) and more often required treatment with N-acetyl cysteine (71% v. 43%). These results highlight the need for safer home storage of paracetamol and consideration of reducing pack size limits on paracetamol that can be purchased.

Background The CaRi-Heart® device estimates risk of 8-year cardiac death, using a prognostic model, which includes perivascular fat attenuation index, atherosclerotic plaque burden and clinical risk factors. Objectives To provide an Early Value Assessment of the potential of CaRi-Heart Risk to be an effective and cost-effective adjunctive investigation for assessment of cardiac risk, in people with stable chest pain/suspected coronary artery disease, undergoing computed tomography coronary angiography. This assessment includes conceptual modelling which explores the structure and evidence about parameters required for model development, but not development of a full executable cost-effectiveness model. Data sources Twenty-four databases, including MEDLINE, MEDLINE In-Process and EMBASE, were searched from inception to October 2022. Methods Review methods followed published guidelines. Study quality was assessed using Prediction model Risk Of Bias ASsessment Tool. Results were summarised by research question: prognostic performance; prevalence of risk categories; clinical effects; costs of CaRi-Heart. Exploratory searches were conducted to inform conceptual cost-effectiveness modelling. Results The only included study indicated that CaRi-Heart Risk may be predictive of 8 years cardiac death. The hazard ratio, per unit increase in CaRi-Heart Risk, adjusted for smoking, hypercholesterolaemia, hypertension, diabetes mellitus, Duke index, presence of high-risk plaque features and epicardial adipose tissue volume, was 1.04 (95% confidence interval 1.03 to 1.06) in the model validation cohort. Based on Prediction model Risk Of Bias ASsessment Tool, this study was rated as having high risk of bias and high concerns regarding its applicability to the decision problem specified for this Early Value Assessment. We did not identify any studies that reported information about the clinical effects or costs of using CaRi-Heart to assess cardiac risk. Exploratory searches, conducted to inform the conceptual cost-effectiveness modelling, indicated that there is a deficiency with respect to evidence about the effects of changing existing treatments or introducing new treatments, based on assessment of cardiac risk (by any method), or on measures of vascular inflammation (e.g. fat attenuation index). A de novo conceptual decision-analytic model that could be used to inform an early assessment of the cost effectiveness of CaRi-Heart is described. A combination of a short-term diagnostic model component and a long-term model component that evaluates the downstream consequences is anticipated to capture the diagnosis and the progression of coronary artery disease. Limitations The rapid review methods and pragmatic additional searches used to inform this Early Value Assessment mean that, although areas of potential uncertainty have been described, we cannot definitively state where there are evidence gaps. Conclusions The evidence about the clinical utility of CaRi-Heart Risk is underdeveloped and has considerable limitations, both in terms of risk of bias and applicability to United Kingdom clinical practice. There is some evidence that CaRi-Heart Risk may be predictive of 8-year risk of cardiac death, for patients undergoing computed tomography coronary angiography for suspected coronary artery disease. However, whether and to what extent CaRi-Heart represents an improvement relative to current standard of care remains uncertain. The evaluation of the CaRi-Heart device is ongoing and currently available data are insufficient to fully inform the cost-effectiveness modelling. Future work A large (n = 15,000) ongoing study, NCT05169333, the Oxford risk factors and non-invasive imaging study, with an estimated completion date of February 2030, may address some of the uncertainties identified in this Early Value Assessment. Study registration This study is registered as PROSPERO CRD42022366496. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Evidence Synthesis programme (NIHR award ref: NIHR135672) and is published in full in Health Technology Assessment; Vol. 28, No. 31. See the NIHR Funding and Awards website for further award information. Plain language summary Coronary artery disease affects around 2.3 million people in the United Kingdom. It is caused by a build-up of fatty plaques on the walls of the blood vessels that supply the heart muscle. This can reduce the flow of blood to the heart and result in people experiencing chest pain (angina), especially when they exercise. Over time, the fatty plaques can grow and block more or all of the artery and blood clots can also form, causing blockage. A heart attack happens when the supply of blood to the heart muscle is blocked. People who have episodes of chest pain, whose doctors think that they may have coronary artery disease, can have a type of imaging (computed tomography coronary angiography) which shows whether there is any narrowing of their coronary arteries. When offering treatment, specialist heart doctors are likely to consider a person’s symptoms and other risk factors (such as family history of heart disease, diabetes and smoking history), as well as how much narrowing of the arteries has happened. CaRi-Heart® is a computer programme that uses information about inflammation in a person’s coronary arteries, together with recognised risk factors, such as age, sex, smoking, high cholesterol levels, high blood pressure and diabetes, to estimate an individual’s risk of dying from a heart attack in the next 8 years. There is evidence that CaRi-Heart® is better at estimating this risk than using information recognised risk factors alone. However, there is a lack of information about how treatment could change as a result of using CaRi-Heart® and whether any changes would improve outcomes for patients. There is also a lack of information about how much CaRi-Heart® would cost the National Health Service. Scientific summary Background Coronary artery disease (CAD) and acute myocardial infarction (AMI) are a significant health burden in the UK, with ischaemic heart disease being the leading cause of death in males. Guidelines from the National Institute for Health and Care Excellence (NICE) and the European Society of Cardiology (ESC) recommend computed tomography coronary angiography (CTCA) for the investigation of CAD in people with stable chest pain. CTCA provides a visualisation of the coronary arteries, which is used to identify plaques, to quantify the extent of any stenosis of the coronary arteries and the length and location of the affected area, and to quantify the extent of coronary artery calcification. Information provided by CTCA is structural rather than functional. Acute coronary events can arise from unstable, but anatomically non-significant, atherosclerotic plaques. The vascular inflammatory response is a modulator of atherogenesis and can be a factor in plaque rupture, leading to acute coronary events. CaRi-Heart® is a cloud-based CE-marked medical device (Caristo Diagnostics Ltd, Oxford, UK) that analyses images from CTCA scans to provide information about inflammation in the coronary arteries. The CaRi-Heart device uses this information to generate a perivascular fat attenuation index (FAI) score. It then estimates individual patient risk of 8-year cardiac death with a prognostic model, which includes the perivascular FAI score, as well as atherosclerotic plaque burden and clinical risk factors. This Early Value Assessment (EVA) considers whether CaRi-Heart Risk has potential to provide an effective, safe and cost-effective adjunctive investigation for assessment of cardiac risk, in people with stable chest pain/suspected CAD, who are undergoing CTCA. This assessment does not include the development of an executable cost-effectiveness model but does include conceptual modelling which explores the structure and evidence about parameters required for model development. Objectives A series of research questions were defined that could inform both a full assessment of the clinical and cost effectiveness of using CaRi-Heart, as an adjunctive investigation for assessment of cardiac risk, in people with stable chest pain/suspected CAD, who are undergoing CTCA and consideration of the potential of this technology to be cost-effective: What is the prognostic performance of CaRi-Heart, in people with stable chest pain, who are undergoing CTCA, where: the dependent variable is cardiac death? the dependent variable is a major adverse cardiovascular event (MACE)? What is the prevalence of ‘low’, ‘medium’ and ‘high’ CaRi-Heart Risk in people with no evidence of CAD, people with evidence of non-obstructive CAD and people with evidence of obstructive CAD, based on currently available CTCA imaging? What are the clinical effects of using CaRi-Heart to assess cardiac risk? How does CaRi-Heart Risk affect treatment decisions and patient adherence in people with no evidence of CAD, people with evidence of non-obstructive CAD and people with evidence of obstructive CAD, based on currently available CTCA imaging? What are the clinical effects of any changes to treatment, based on CaRi-Heart Risk, in people with no evidence of CAD, people with evidence of non-obstructive CAD and people with evidence of obstructive CAD, based on currently available CTCA imaging? What are the costs, from a UK NHS and Personal Social Services (PSS) perspective, using CaRi-Heart, as an adjunctive investigation for assessment of cardiac risk, in people with stable chest pain, who are undergoing CTCA? How might a conceptual model be specified in terms of structure and evidence required for parameterisation in order to estimate the cost-effectiveness of CaRi-Heart in people with stable chest pain, who are undergoing CTCA? Methods Questions 1–4 were addressed using a rapid review process. Twenty-four databases were searched from inception to October 2022, using a variety of databases including MEDLINE, EMBASE, Cochrane, Database of Abstracts of Reviews of Effects (DARE), Health Technology Assessment (HTA), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Kleijnen Systematic Reviews Ltd (KSR) Evidence and Epistemonikos. One reviewer screened titles and abstracts of all reports identified by the searches, and a minimum of 20% were independently screened by a second reviewer. Full copies of all studies deemed potentially relevant, by either reviewer, were obtained and both reviewers independently assessed these for inclusion; any disagreements were resolved by consensus or discussion with a third reviewer. Data were extracted by one reviewer and checked by a second reviewer; any disagreements were resolved by consensus or discussion with a third reviewer. Study quality was assessed using appropriate risk-of-bias tools. Results were summarised by research question: prognostic performance; prevalence of risk categories; clinical effects; costs of CaRi-Heart. In addition to the rapid review, evidence that might be required to inform parameterisation of a future cost-effectiveness model was explored, as part of the conceptual modelling process, using a pragmatic, iterative searching approach; model parameterisation questions, other than costs, were not included in the rapid review. Results Rapid review The rapid review identified one relevant model development and validation study, which included a total of 3912 patients who were undergoing clinically indicated CTCA for the evaluation of stable coronary disease. The training/development (USA) cohort comprised 2040 patients, with a median (range) follow-up duration of 53.8 (4–105) months; a total of 85 deaths were reported during follow-up, of which 48 were cardiac. The validation (Germany) cohort comprised 1872 patients, with a median (range) follow-up duration of 72 (51–109) months; there were a total of 114 deaths during follow-up, of which 26 were confirmed cardiac deaths and 16 were deaths of unknown cause. Based on Prediction model Risk Of Bias ASsessment Tool (PROBAST), this study was rated as having high risk of bias and high concerns regarding its applicability to the decision problem specified for this EVA. Importantly, there has been no external validation of the CaRi-Heart Risk model, as the reported validation data set was used in a previous study to develop methods and thresholds for the main imaging predictors (FAI scores). With respect to applicability, the CaRi-Heart study evaluated CaRi-Heart Risk for the prediction of 8-year cardiac death; it did not consider prediction of cardiac risk, as specified in the scope for this EVA (i.e. including risk of non-fatal adverse cardiovascular events). In addition, it is unclear whether the clinical comparator model can be considered representative of standard of care in the UK NHS. The included study provided information relevant to research question 1: ‘What is the prognostic performance of CaRi-Heart, in people with stable chest pain, who are undergoing CTCA where: (1) the dependent variable is cardiac death? (2) the dependent variable is MACE?’ The hazard ratio (HR) for 8-year cardiac death, per unit increase in CaRi-Heart Risk, adjusted for ‘traditional risk factors’ (smoking, hypercholesterolaemia, hypertension, diabetes mellitus, Duke index, presence of high-risk plaque features and epicardial adipose tissue volume), was 1.05 [95% confidence interval (CI) 1.03 to 1.06] in the training/development cohort and 1.04 (95% CI 1.03 to 1.06) in the validation cohort. With respect to the subgroups of clinical interest, the predictive value of the CaRi-Heart Risk model was consistent across patients with and without obstructive CAD. In addition, the results of the included study indicated that the CaRi-Heart Risk model showed improved risk discrimination, when compared to a baseline clinical risk model, which included age, sex, hypertension, hypercholesterolaemia, diabetes mellitus and smoking (Δ c-statistic 0.149, p 10%) CaRi-Heart Risk scores, estimated from this study, was 3060/3912 (78.2%), 423/3912 (10.8%) and 429/3912 (11.0%), respectively. No studies were identified which addressed research question 3 (‘What are the clinical effects of using CaRi-Heart to assess cardiac risk?) or research question 4 (‘What are the costs, from a UK NHS and PSS perspective, using CaRi-Heart®, as an adjunctive investigation for assessment of cardiac risk, in people with stable chest pain, who are undergoing CTCA?’). Exploratory searches to inform model parameterisation Additional exploratory searches were conducted to inform the conceptual cost-effectiveness modelling, focusing on changes to treatment that might be made based on CaRi-Heart Risk and potential alternative technologies to CaRi-Heart. The results of these searches indicated that there is a deficiency with respect to evidence about the effects of changing existing treatments or introducing new treatments, based on assessment of cardiac risk (by any method), or on measures of vascular inflammation, such as perivascular FAI. However, the evidence is broadly supportive of a positive relationship between FAI and risk of adverse coronary events and hence of the future inclusion of FAI as an alternative technology (in evaluations of the CaRi-Heart device) should a method of measurement become commercially available in the UK NHS. The evidence also supports the efficacy of colchicine for secondary prevention of adverse cardiac events in unselected patients with CAD but does not provide unequivocal evidence about the mechanism by which this effect is mediated. Importantly, for the aims of this EVA, the evidence identified does not provide any indication of the efficacy of targeting colchicine treatment using CaRi-Heart Risk or separate measures of coronary inflammation, such as FAI. It should also be noted that colchicine is not currently recommended by NICE, or licensed in the UK, for this indication. Finally, the evidence suggests some uncertainty about whether and to what extent the efficacy of statins, for the secondary prevention of MACE in people with CAD, may vary with baseline risk assessed using currently available methods. In addition, there is currently no information about the effects of introducing statin treatment or changing the dose of existing statin treatment, based on CaRi-Heart Risk or on any assessment of coronary artery inflammation. Conceptual modelling A de novo conceptual decision-analytic model that could be used to inform an early assessment of the cost effectiveness of CaRi-Heart has been described. A combination of a short-term diagnostic model component and a long-term model component that evaluated the downstream consequences is anticipated to capture the diagnosis and the progression of CAD, respectively. It is expected that for the CaRi-Heart strategy, the initial diagnostic groups based on CTCA only would be, in turn, further split by the CaRi-Heart information into groups of low, medium or high CaRi-Heart Risk. If other competing alternatives are identified, those could be added to the model, if there is sufficient available evidence. Conclusions The rapid review methods and pragmatic approach to additional exploratory searches used to inform this EVA mean that, although areas of potential uncertainty have been described, our findings cannot be used to definitively state where there are evidence gaps. The evidence about the clinical utility of CaRi-Heart Risk is, as yet, sparse and is subject to considerable limitations, both in terms of risk of bias and applicability to UK clinical practice. There is some evidence to indicate that CaRi-Heart Risk may be predictive of an individual patient’s 8-year risk of cardiac death, for patients undergoing CTCA for suspected CAD. However, whether and to what extent CaRi-Heart represents an improvement relative to current standard of care remains unclear. Currently available data are insufficient to fully inform cost-effectiveness modelling. A large (n = 15,000) ongoing study, NCT05169333, the Oxford risk factors and non-invasive imaging (ORFAN) study, with an estimated completion date of February 2030, may address some of the uncertainties identified in this EVA. Suggested research priorities External validation of the CaRi-Heart Risk model should be considered a high priority. The external validation process could also be used to address some of the applicability concerns, for example, the ability of CaRi-Heart Risk to predict non-fatal adverse cardiovascular events (in addition to cardiac death) could be considered. It remains unclear whether and to what extent CaRi-Heart represents an improvement relative to current standard of care; this is largely because the definition of standard of care and hence the applicability of the comparator used in the CaRi-Heart study are uncertain. If a consensus could be reached, among clinical experts, as to what should constitute standard of care, then the prognostic performance of CaRi-Heart Risk could be compared to this standard. There is currently a lack of information about the costs, from a UK NHS and PSS perspective, using CaRi-Heart, as an adjunctive investigation for assessment of cardiac risk, in people with stable chest pain, who are undergoing CTCA. The company have indicated that the ORFAN study will collect data on costs to the NHS of adding CaRi-Heart to CTCA, including cardiologists’ time in training to interpret CaRi-Heart analyses, and the implementation costs per CTCA (if any) added to the price of a CaRi-Heart analysis to estimate the total cost per CTCA of introducing CaRi-Heart into the NHS. There is also a lack of information about the clinical effects of any changes to treatment/management that may be made as a result of adding assessment using CaRi-Heart Risk to current standard of care, in patients undergoing CTCA for suspected CAD. The optimum study design would be a randomised controlled trial (RCT) or cluster RCT, where patients or study centres are randomised to receive CTCA with or without the addition of CaRi-Heart Risk assessment, and information about changes to treatment/management and long-term clinical effects is collected. Observational study designs, including ‘before and after’ implementation studies or using matching techniques to provide a control, could provide an alternative approach. Acknowledging that the collection of data about the long-term clinical effects of using CaRi-Heart Risk will take a number of years, alternative, pragmatic approaches to populating this component of a full cost-effectiveness model may be considered useful. Such approaches could include estimation of the potential effects of treatment changes based on risk-stratified effects of treatment (e.g. statins), where risk stratification has been based on methods other than CaRi-Heart Risk and/or estimation of the potential effects of introducing new treatments (e.g. colchicine) where the ‘target condition’ (coronary inflammation) has been assessed by methods other than CaRi-Heart Risk (e.g. FAI alone). Study registration This study is registered as PROSPERO CRD42022366496. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Evidence Synthesis programme (NIHR award ref: NIHR135672) and is published in full in Health Technology Assessment; Vol. 28, No. 31. See the NIHR Funding and Awards website for further award information.

Background During the initial phases of the COVID-19 pandemic, children and young people (CYP) faced significant restrictions. The virus and mitigation approaches significantly impacted how health services could function and be safely delivered. Aims To investigate the impact of COVID-19 lockdowns on CYP psychiatric admission trends during lockdown 1 (started 23 Mar 2020) and lockdown 2 (started 5 Nov 2020) of the COVID-19 pandemic in England. Method Routinely collected, retrospective English administrative data regarding psychiatric hospital admissions, length of stay and patient demographic factors were analysed using an interrupted time series analysis (ITSA) to estimate the impact of COVID-19 lockdowns 1 and 2 on service use trends. We analysed data of 6250 CYP (up to 18 years of age) using ordinary least squares (OLS) regression analysis with Newey–West standard errors to handle autocorrelation and heteroscedasticity. Results Psychiatric hospital admissions for CYP significantly fell during lockdown 1, and then fell even further during lockdown 2. A greater proportion of admissions during lockdown were out of area or to independent sector units. During lockdown, the average age of CYP admitted was higher, and a greater proportion were female. There was also a significant increase in the proportion of looked-after children and CYP from the most socioeconomically deprived areas admitted during lockdown 2. Conclusions During both lockdowns, fewer CYP had psychiatric admissions. The subsequent rise in admissions for more socioeconomically deprived CYP and looked-after children suggests that these CYP may have been disproportionately affected by the pandemic, or overlooked during earlier phases.

The personalised oncology paradigm remains challenging to deliver despite technological advances in genomics-based identification of actionable variants combined with the increasing focus of drug development on these specific targets. To ensure we continue to build concerted momentum to improve outcomes across all cancer types, financial, technological and operational barriers need to be addressed. For example, complete integration and certification of the ‘molecular tumour board’ into ‘standard of care’ ensures a unified clinical decision pathway that both counteracts fragmentation and is the cornerstone of evidence-based delivery inside and outside of a research setting. Generally, integrated delivery has been restricted to specific (common) cancer types either within major cancer centres or small regional networks. Here, we focus on solutions in real-world integration of genomics, pathology, surgery, oncological treatments, data from clinical source systems and analysis of whole-body imaging as digital data that can facilitate cost-effectiveness analysis, clinical trial recruitment, and outcome assessment. This urgent imperative for cancer also extends across the early diagnosis and adjuvant treatment interventions, individualised cancer vaccines, immune cell therapies, personalised synthetic lethal therapeutics and cancer screening and prevention. Oncology care systems worldwide require proactive step-changes in solutions that include inter-operative digital working that can solve patient centred challenges to ensure inclusive, quality, sustainable, fair and cost-effective adoption and efficient delivery. Here we highlight workforce, technical, clinical, regulatory and economic challenges that prevent the implementation of precision oncology at scale, and offer a systematic roadmap of integrated solutions for standard of care based on minimal essential digital tools. These include unified decision support tools, quality control, data flows within an ethical and legal data framework, training and certification, monitoring and feedback. Bridging the technical, operational, regulatory and economic gaps demands the joint actions from public and industry stakeholders across national and global boundaries.

Abstract Background Stress echocardiography is widely used to detect coronary artery disease, but little evidence on downstream hospital costs in real-world practice is available. We examined how stress echocardiography accuracy and downstream hospital costs vary across NHS hospitals and identified key factors that affect costs to help inform future clinical planning and guidelines. Methods Data on 7636 patients recruited from 31 NHS hospitals within the UK between 2014 and 2020 as part of EVAREST/BSE-NSTEP clinical study, were used. Data included all diagnostic tests, procedures, and hospital admissions for 12 months after a stress echocardiogram and were costed using the NHS national unit costs. A decision tree was built to illustrate the clinical pathway and estimate average downstream hospital costs. Multi-level regression analysis was performed to identify variation in accuracy and costs at both patient, procedural, and hospital level. Linear regression and extrapolation were used to estimate annual hospital cost-savings associated with increasing predictive accuracy at hospital and national level. Results Stress echocardiography accuracy varied with patient, hospital and operator characteristics. Hypertension, presence of wall motion abnormalities and higher number of hospital cardiology outpatient attendances annually reduced accuracy, adjusted odds ratio of 0.78 (95% CI 0.65 to 0.93), 0.27 (95% CI 0.15 to 0.48), 0.99 (95% CI 0.98 to 0.99) respectively, whereas a prior myocardial infarction, angiotensin receptor blocker medication, and greater operator experience increased accuracy, adjusted odds ratio of 1.77 (95% CI 1.34 to 2.33), 1.64 (95% CI 1.22 to 2.22), and 1.06 (95% CI 1.02 to 1.09) respectively. Average downstream costs were £646 per patient (SD 1796) with significant variation across hospitals. The average downstream costs between the 31 hospitals varied from £384–1730 per patient. False positive and false negative tests were associated with average downstream costs of £1446 (SD £601) and £4192 (SD 3332) respectively, driven by increased non-elective hospital admissions, adjusted odds ratio 2.48 (95% CI 1.08 to 5.66), 21.06 (95% CI 10.41 to 42.59) respectively. We estimated that an increase in accuracy by 1 percentage point could save the NHS in the UK £3.2 million annually. Conclusion This study provides real-world evidence of downstream costs associated with stress echocardiography practice in the UK and estimates how improvements in accuracy could impact healthcare expenditure in the NHS. A real-world downstream costing approach could be adopted more widely in evaluation of imaging tests and interventions to reflect actual value for money and support realistic planning.

BackgroundPsychotic disorders are severe and prevalent mental health conditions associated with long-term disability, reduced quality of life, and substantial economic costs. Early Intervention in Psychosis (EIP) services aim to provide timely and comprehensive treatment for psychotic disorders, and EIP service input is associated with improved outcomes. However, there is limited understanding of the specific components of EIP care that contribute to these improvements. There is significant nationwide variability in the commissioning and delivery of EIP, with individuals receiving different packages of components from different services. In this study, we seek to explore associations between EIP components and clinically significant outcomes, in order to understand the mechanisms underlying improved psychosis care.MethodsThis national retrospective cohort study will utilize data from the 2019 National Clinical Audit of Psychosis (NCAP), examining the care received by 10,560 individuals treated by EIP services in England. Exposure data from the NCAP, capturing the components of care delivered by EIP services, will be linked with outcome data from routine NHS Digital datasets over a three-year follow-up period. This will be the first study to use this method to examine this population in England. The primary outcomes will be surrogate measures of relapse of psychosis (hospital admission and referral to community-based crisis intervention services). Secondary outcomes include duration of admissions, emergency hospital attendances, episodes of detention under the Mental Health Act, and all-cause mortality. We will use multilevel regression to examine associations between exposures and outcome events. We will handle missing data using appropriate imputation techniques.DiscussionThis study aims to provide valuable insights into the long-term effects of variations in EIP service delivery. The study involves a large, diverse cohort including individuals treated by every EIP service in England. While there are limitations inherent in the observational nature of the study, any associations identified will be of great relevance to clinicians, researchers, and policymakers seeking to optimize EIP care. The results will enable more targeted treatment planning, resource allocation, and potential innovations in EIP care, ultimately leading to improved prognoses for people experiencing psychosis.

Abstract Aim To independently assess the impact of mandatory testing using an extended DPYD variant panel (ToxNav®) and consequent dose adjustment of Capecitabine/5-FU on recorded quantitative toxicity, symptoms of depression, and hospital costs. Methods We used propensity score matching (PSM) to match 466 patients tested with ToxNav® with 1556 patients from a historical cohort, and performed regression analysis to estimate the impact of ToxNav®on toxicity, depression, and hospital costs. Results ToxNav® appeared to reduce the likelihood of experiencing moderate (OR: 0.59; 95%CI: 0.45–0.77) and severe anaemia (OR: 0.55; 95%CI: 0.33–0.90), and experience of pain for more than 4 days a week (OR: 0.50; 95%CI: 0.30–0.83), while it increased the likelihood of mild neutropenia (OR: 1.73; 95%CI: 1.27–2.35). It also reduced the cost of chemotherapy by 12% (95%CI: 3–31) or £9765, the cost of non-elective hospitalisation by 23% (95%CI: 8–36) or £2331, and the cost of critical care by 21% (95%CI: 2–36) or £1219 per patient. For the DPYD variant associated with critical risk of toxicity (rs3918290), the improved non-elective hospital costs were > £20,000, whereas variants associated with hand-foot syndrome toxicity had no detectable cost improvement. Conclusion Upfront testing of DPYD variants appears to reduce the toxicity burden of Capecitabine and 5-FU in cancer patients and can lead to substantial hospital cost savings, only if the dose management of the drugs in response to variants detected is standardised and regulated.

Abstract Background Cost-effectiveness analysis needs to be considered when introducing new tools and treatments to clinical services. The number of new assessment tools in mental health has rapidly expanded, including suicide risk assessment. Such suicide-based assessments, when linked to preventative interventions, are integral to high-quality mental health care for people with severe mental illness (SMI). We examined the cost implications of implementing Oxford Mental Illness and Suicide (OxMIS), an evidence-based, scalable suicide risk assessment tool that provides probabilistic estimates of suicide risk over 12 months for people with SMI in England. Methods We developed a decision analytic model using secondary data to estimate the potential cost-effectiveness of incorporating OxMIS into clinical decision-making in secondary care as compared to usual care. Cost-effectiveness was measured in terms of costs per quality-adjusted life years (QALYs) gained. Uncertainty was addressed with deterministic and probabilistic sensitivity analysis. Results Conducting suicide risk assessment with OxMIS was potentially cheaper than clinical risk assessment alone by £250 (95% confidence interval, −786;31) to £599 (−1,321;−156) (in 2020–2021 prices) per person with SMI and associated with a small increase in quality of life (0.01 [−0.03;0.05] to 0.01 QALY, [−0.04;0.07]). The estimated incremental cost-effectiveness ratio of implementing OxMIS was cost saving. Using probabilistic sensitivity analysis, 99.96% of 10,000 simulations remained cost saving. Conclusion Cost-effectiveness analysis can be conducted on risk prediction models. Implementing one such model that focuses on suicide risk in a high-risk population can lead to cost savings and improved health outcomes, especially if explicitly linked to preventative treatments.

Introduction: Child Safeguarding Services intervene in situations where a child is at risk of serious emotional or physical harm. The response will vary according to the level of risk, but in serious cases, a child may need to be removed from danger and cared for by foster parents either temporarily or permanently. The number of children being taken into care has increased markedly in recent years in the United Kingdom. Oxfordshire County Council (OCC) is implementing a new approach to the welfare of children (Family Solutions Plus; FSP) in which the focus is to support the whole family and ideally reduce the need for foster care. In this paper, we describe a proposed programme of evaluation to examine the impact of FSP on the time children are in contact with services, the nature of the support provided, experience of children and families, the experience of staff, and longer term outcomes for children, particularly whether they remain within the family or need to be cared for outside the home. Methods and analysis: A mixed methods approach will be taken in an observational retrospective study of children’s social care services. Quantitative research will include descriptive analysis on data routinely collected by OCC, examining the effect on time spent in services, outcomes for children and how these outcomes are mediated by family characteristics and circumstances. Qualitative research will be carried out using individual interviews and focus groups with children, families and staff in the teams providing family safeguarding services to capture their experiences with the new model. Ethics and dissemination: This project has been registered with the OCC as a service evaluation. The qualitative studies will seek ethical approval from Oxford University Ethics Committee. A local data sharing agreement will govern the transfer of quantitative data. Results will be disseminated through newsletters, community forums, professional publications and conference presentations to national and international audiences.

Background: The emergence of Integrated Care Systems (ICSs) across England poses an additional challenge and responsibility for local commissioners to accelerate the implementation of integrated care programmes and improve the overall efficiency across the system. To do this, ICS healthcare commissioners could learn from the experience of the former local commissioning structures and identify areas of improvement in the commissioning process. This study describes the investment decision process in integrated care amid the transition toward ICSs, highlights challenges, and provides recommendations to inform ICSs in their healthcare commissioning role. Methods: Twenty-six semi-structured interviews were conducted with local commissioners and other relevant stakeholders in South East England in 2021. Interviews were supplemented with literature. Results: England’s local healthcare commissioning has made the transition towards a new organisational architecture, with some integrated care programmes running, and a dual top-down and bottom-up prioritisation process in place. The commissioning and consequent development of integrated care programmes have been hindered by various barriers, including difficulties in accessing and using information, operational challenges, and resource constraints. Investment decisions have mainly been driven by national directives and budget considerations, with a mixture of subjective and objective approaches. A systematic and data-driven framework could replace this ad-hoc prioritisation of integrated care and contribute to a more rational and transparent commissioning process. Conclusion: The emerging ICSs seem to open an opportunity for local commissioners to strengthen the commissioning process of integrated care with evidence-based priority-setting approaches similar to the well-established health technology assessment framework at the national level.

Abstract Purpose The aim of this work was to develop a mapping algorithm for estimating EuroQoL 5 Dimension (EQ-5D) utilities from responses to the Long-Term Conditions Questionnaire (LTCQ), thus increasing LTCQ’s potential as a comprehensive outcome measure for evaluating integrated care initiatives. Methods We combined data from three studies to give a total sample of 1334 responses. In each of the three datasets, we randomly selected 75% of the sample and combined the selected random samples to generate the estimation dataset, which consisted of 1001 patients. The unselected 25% observations from each dataset were combined to generate an internal validation dataset of 333 patients. We used direct mapping models by regressing responses to the LTCQ-8 directly onto EQ-5D-5L and EQ-5D-3L utilities as well as response (or indirect) mapping to predict the response level that patients selected for each of the five EQ-5D-5L domains. Several models were proposed and compared on mean squared error and mean absolute error. Results A two-part model with OLS was the best performing based on the mean squared error (0.038) and mean absolute error (0.147) when estimating the EQ-5D-5L utilities. A multinomial response mapping model using LTCQ-8 responses was used to predict EQ-5D-5L responses levels. Conclusions This study provides a mapping algorithm for estimating EQ-5D utilities from LTCQ responses. The results from this study can help broaden the applicability of the LTCQ by producing utility values for use in economic analyses.

Abstract Background In many high-income countries, primary care practitioners are the main point of referral for specialist mental health services. In England, Child and Adolescent Mental Health Services (CAMHS) are increasingly adopting a Single Point of Access (SPA) to streamline referrals and introduce self and parent/carer-referrals. This involves a significant shift of responsibility from primary care towards CAMHS who adopt a more active role as gatekeeper for their service. This study evaluates the adoption of a SPA in CAMHS across a large region in England. Methods We conducted an observational mixed methods study in two CAMHS from January 2018 to March 2019 to evaluate the adoption of a SPA. We collected quantitative data from electronic patient records and qualitative data through ethnographic observation and in-depth interviews of staff and stakeholders with experience of using CAMHS. Additional data on volumes was shared directly from the SPAs and a further snapshot of 1 week’s users was collected. Results A similar SPA model emerged across the two services. Staff were positive about what the model could achieve and access rates grew quickly following awareness-raising activities. Despite the initial focus being on a telephone line, online referrals became the more regularly used referral method. Increased access brought challenges in terms of resourcing, including identifying the right staff for the role of call handlers. A further challenge was to impose consistency on triage decisions, which required structured information collection during the assessment process. Similar to GP referrals, those self-referring via the SPA were mainly from the least deprived areas. Conclusions The introduction of a SPA has the potential to improve young people’s access to mental health services. By addressing some of the barriers to access, simplifying where to go to get help and making it easier to contact the service directly, a SPA can help more individuals and families access timely support. However, the introduction of a SPA does not in itself expand the capacity of CAMHS, and therefore expectations within services and across sectors need to be tempered accordingly. SPA services providing different referral approaches can further improve access for the harder to reach populations.

Abstract Background The cluster randomized controlled trial on (cost-)effectiveness of integrated chronic obstructive pulmonary disease (COPD) management in primary care (RECODE) showed that integrated disease management (IDM) in primary care had no effect on quality of life (QOL) in COPD patients compared with usual care (guideline-supported non-programmatic care). It is possible that only a subset of COPD patients in primary care benefit from IDM. We therefore examined which patients benefit from IDM, and whether patient characteristics predict clinical improvement over time. Method Post-hoc analyses of the RECODE trial among 1086 COPD patients. Logistic regression analyses were performed with baseline characteristics as predictors to examine determinants of improvement in QOL, defined as a minimal decline in Clinical COPD Questionnaire (CCQ) of 0.4 points after 12 and 24 months of IDM. We also performed moderation analyses to examine whether predictors of clinical improvement differed between IDM and usual care. Results Regardless of treatment type, more severe dyspnea (MRC) was the most important predictor of clinically improved QOL at 12 and 24 months, suggesting that these patients have most room for improvement. Clinical improvement with IDM was associated with female gender (12-months) and being younger (24-months), and improvement with usual care was associated with having a depression (24-months). Conclusions More severe dyspnea is a key predictor of improved QOL in COPD patients over time. More research is needed to replicate patient characteristics associated with clinical improvement with IDM, such that IDM programs can be offered to patients that benefit the most, and can potentially be adjusted to meet the needs of other patient groups as well. Trial registration Netherlands Trial Register, NTR2268 . Registered 31 March 2010.

Abstract Background Over the last few decades, effective psychological treatments for posttraumatic stress disorder (PTSD) have been developed, but many patients are currently unable to access these treatments. There is initial evidence that therapist-assisted internet-based psychological treatments are effective for PTSD and may help increase access, but it remains unclear which of these treatments work best and are most acceptable to patients. This randomised controlled trial will compare a trauma-focussed and a nontrauma-focussed therapist-assisted cognitive behavioural Internet treatment for PTSD: Internet-delivered cognitive therapy for PTSD (iCT-PTSD) and internet-delivered stress management therapy (iStress-PTSD). Methods/design The study is a single-blind, randomised controlled trial comparing iCT-PTSD, iStress-PTSD and a 13-week wait-list condition, with an embedded process study. Assessors of treatment outcome will be blinded to trial arm. Two hundred and seventeen participants who meet DSM-5 criteria for PTSD will be randomly allocated by a computer programme to iCT-PTSD, iStress-PTSD or wait-list at a 3:3:1 ratio. The primary assessment point is at 13 weeks, and further assessments are taken at 6, 26, 39 and 65 weeks. The primary outcome measure is the severity of PTSD symptoms as measured by the PTSD Checklist for DSM-5 (PCL-5). Secondary measures of PTSD symptoms are the Clinician Administered PTSD Scale for DSM-5 (CAPS-5) and the Impact of Event Scale-Revised (IES-R). Other symptoms and well-being will be assessed with the Patient Health Questionnaire (PHQ-9), Generalised Anxiety Disorder Scale (GAD-7), WHO (Five) Well-Being Index, Work and Social Adjustment Scale (WSAS), Endicott Quality of Life Scale (QoL), and Insomnia Sleep Index (ISI). Health economics analyses will consider quality of life, productivity, health resource utilisation, employment status and state benefits, and treatment delivery costs. Process analyses will investigate candidate mediators and moderators of outcome. Patient experience will be assessed by interview and questionnaire. Discussion This study will be the first to compare the efficacy of a trauma-focussed and nontrauma-focussed therapist-assisted online cognitive behavioural treatment for people with posttraumatic stress disorder. Trial registration ISRCTN16806208 . Registered prospectively on 5 January 2018.

Objective To evaluate the value of the person-centred, integrated care programme Care Chain Frail Elderly (CCFE) compared with usual care, using multicriteria decision analysis (MCDA).Design In a 12-month quasi-experimental study, triple-aim outcomes were measured at 0, 6 and 12 months by trained interviewers during home-visits.Setting Primary care, community-based elderly care.Participants 384 community-dwelling frail elderly were enrolled. The 12-month completion rate was 70% in both groups. Propensity score matching was used to balance age, gender, marital status, living situation, education, smoking status and 3 month costs prior to baseline between the two groups.Intervention The CCFE is an integrated care programme with unique features like the presence of the elderly and informal caregiver at the multidisciplinary team meetings, and a bundled payment.Primary and secondary outcomes measures The MCDA results in weighted overall value scores that combines the performance on physical functioning, psychological well-being, social relationships and participation, enjoyment of life, resilience, person-centredness, continuity of care and costs, with importance weights of patients, informal caregivers, professionals, payers and policy-makers.Results At 6 months, the overall value scores of CCFE were higher in all stakeholder groups, driven by enjoyment of life (standardised performance scores 0.729 vs 0.685) and person-centredness (0.749 vs 0.663). At 12 months, the overall value scores in both groups were similar from a patient’s perspective, slightly higher for CCFE from an informal caregiver’s and professional’s perspective, and lower for CCFE from a payer’s and policy-maker’s perspective. The latter was driven by a worse performance on physical functioning (0.682 vs 0.731) and higher costs (€22 816 vs €20 680).Conclusions The MCDA indicated that the CCFE is the preferred way of delivering care to frail elderly at 6 months. However, at 12 months, MCDA results showed little difference from the perspective of patients, informal caregivers and professionals, while payers and policy-makers seemed to prefer usual care.

Background: Evidence is required to guide the redesign of health care for older people who require hospital admission. Objectives: We assessed the clinical effectiveness and cost-effectiveness of geriatrician-led admission avoidance hospital at home with comprehensive geriatric assessment, the experiences of older people and their caregivers, and how the services differed. Design: A multisite, randomised, open trial of comprehensive geriatric assessment hospital at home, compared with admission to hospital, using a 2 : 1 (hospital at home to hospital) ratio, and a parallel economic and process evaluation. Participants were randomised using a secure online system. Setting: Participants were recruited from primary care or acute hospital assessment units from nine sites across the UK. Participants: Older people who required hospital admission because of an acute change in health. Intervention: Geriatrician-led admission avoidance hospital at home with comprehensive geriatric assessment. Main outcome measures: The main outcome, ‘living at home’ (the inverse of death or living in a residential care setting), was measured at 6-month follow-up. Secondary outcomes at 6 months were the incidence of delirium, mortality, new long-term residential care, cognitive impairment, ability to perform activities of daily living, quality-adjusted survival, length of stay and transfer to hospital. Secondary outcomes at 12 months were living at home, new long-term residential care and mortality. Results: Participants were allocated to hospital at home (n = 700) or to hospital (n = 355). All reported relative risks (RRs) were adjusted and are reported for hospital at home compared with hospital. There were no significant differences between the groups in the proportions of patients ‘living at home’ at 6 months [528/672 (78.6%) vs. 247/328 (75.3%), RR 1.05, 95% confidence interval (CI) 0.95 to 1.15; p = 0.36] or at 12 months [443/670 (66.1%) vs. 219/325 (67.4%), RR 0.99, 95% CI 0.89 to 1.10; p = 0.80]; mortality at 6 months [114/673 (16.9%) vs. 58/328 (17.7%), RR 0.98, 95% CI 0.65 to 1.47; p = 0.92] or at 12 months [188/670 (28.1%) vs. 82/325 (25.2%), RR 1.14, 95% CI 0.80 to 1.62]; the proportion of patients with cognitive impairment [273/407 (67.1%) vs. 115/183 (62.8%), RR 1.06, 95% CI 0.93 to 1.21; p = 0.36]; or in ability to perform the activities of daily living as measured by the Barthel Index (mean difference 0.24, 95% CI –0.33 to 0.80; p = 0.411; hospital at home, n = 521 patients contributed data; hospital, n = 256 patients contributed data) or Comorbidity Index (adjusted mean difference 0.0002, 95% CI –0.15 to 0.15; p = 0.10; hospital at home, n = 474 patients contributed data; hospital, n = 227 patients contributed data) at 6 months. The varying denominator reflects the number of participants who contributed data to the different outcomes. There was a significant reduction in the RR of living in residential care at 6 months [37/646 (5.7%) vs. 27/311 (8.7%), RR 0.58, 95% CI 0.45 to 0.76; p

Abstract Background Deterioration in general population mental health since the start of the COVID-19 pandemic has been reported, but the impact of the pandemic on people with severe mental illness (SMI) has received less attention. Aims To understand the impact of the early stages of the pandemic on the patients with SMI, in terms of provision of mental health care and patient outcomes. Method We examined records of 34,446 patients with SMI in Oxford Health Foundation Trust between March 2016 and July 2020. We used interrupted time-series analysis to estimate the immediate and subsequent changes in weekly rates of the use of community mental health services, hospitalization, and patient outcomes (as measured by Health of the Nation Outcome Scales, or HoNOS, scores) during the weeks of lockdown between March 23, 2020 and July 3, 2020. Results Mean total HoNOS scores for all patients deteriorated in the weeks subsequent to lockdown (0.060 per week; 95%CI: 0.033, 0.087). Scores for patients with a history of psychosis deteriorated immediately (0.63; 95% CI: 0.26, 1.0). There was an immediate decrease in weekly referrals to community and outpatient services (−196; 95%CI: −300, −91) and no immediate change in weekly inpatient admissions (−4.2; 95%CI: −9.9, 1.5) or weekly total contacts (−26; 95%CI: −475, 423). Conclusions Patients with SMI were negatively impacted during the early stages of the COVID-19 pandemic. Patients with a history of psychosis experienced distinct and immediate impacts. During the same period, referrals to community and outpatient services fell with no consequent impact on inpatient admissions.

Abstract Background Guidance in England recommends psychosocial assessment when presenting to hospital following self-harm but adherence is variable. There is some evidence suggesting that psychosocial assessment is associated with lower risk of subsequent presentation to hospital for self-harm, but the potential cost-effectiveness of psychosocial assessment for hospital-presenting self-harm is unknown. Methods A three-state four-cycle Markov model was used to assess cost-effectiveness of psychosocial assessment after self-harm compared with no assessment over 2 years. Data on risk of subsequent self-harm and hospital costs of treating self-harm were drawn from the Multicentre Study of Self-Harm in England, while estimates of effectiveness of psychosocial assessment on risk of self-harm, quality of life, and other costs were drawn from literature. Incremental cost-effectiveness ratios (ICERs) for cost per Quality Adjusted Life Year (QALY) gained were estimated. Parameter uncertainty was addressed in univariate and probabilistic sensitivity analyses. Results Cost per QALY gained from psychosocial assessment was £10,962 (95% uncertainty interval [UI] £15,538–£9,219) from the National Health Service (NHS) perspective and £9,980 (95% UI £14,538–£6,938) from the societal perspective. Results were generally robust to changes in model assumptions. The probability of the ICER being below £20,000 per QALY gained was 78%, rising to 91% with a £30,000 threshold. Conclusions Psychosocial assessment as implemented in the English NHS is likely to be cost-effective. This evidence could support adherence to NICE guidelines. However, further evidence is needed about the precise impacts of psychosocial assessment on self-harm repetition and costs to individuals and their families beyond immediate hospital stay.

BackgroundChild and Adolescent Mental Health Services (CAMHS) in England are making significant changes to improve access and effectiveness. This 'transformation' variously involves easier access to services through a Single Point of Access (SPA), more integrated services within CAMHS and enhanced co-provision across education and third sector or non-profit organisations.MethodsA mixed-methods observational study was conducted to explore the process and impact of transformation over four years in two services. Ethnographic observations and in-depth interviews were conducted and Electronic Patient Records with over one million contacts analysed. Difference-in-differences analysis with propensity score matching to estimate the causal impact of the transformation on patient access was utilised.OutcomesSpend and staffing increased across both CAMHS. The SPA had growing rates of self-referral and new care pathways were seeing patients according to expected degree of psychopathology. Third sector partners were providing increasing numbers of low-intensity interventions. Although the majority of staff were supportive of the changes, the process of transformation led to service tensions. In the first year after transformation there was no change in the rate of new patients accessing services or new spells (episodes of care) in the services. However, by year three, the number of new patients accessing CAMHS was 19% higher (Incidence Rate Ratio: 1·19, CI: 1·16, 1·21) and the rate of new spells was 12% higher (Incidence Rate Ratio: 1·12, CI: 1·05, 1·20).InterpretationTransformation investment, both financial and intellectual, can help to increase access to CAMHS in England, but time is needed to realise the benefits of reorganisation.

Background Effective interventions, targeting key contributory causal factors, are needed to prevent the emergence of severe mental health problems in young people. Insomnia is a common clinical issue that is problematic in its own right but that also leads to the development and persistence of psychotic experiences. The implication is that treating sleep problems may prevent the onset of psychosis. We collected initial case series data with 12 young people at ultra-high-risk of psychosis. Post-intervention, there were improvements in sleep, depression and psychotic experiences. Now we test the feasibility of a randomised controlled trial, with a clinical aim to treat sleep problems and hence reduce depression, psychotic experiences, and prevent transition to psychosis.Methods and analysis A randomised controlled feasibility trial will be conducted. Forty patients aged 14 to 25 years who are at ultra-high-risk of psychosis and have sleep disturbance will be recruited from National Health Service (NHS) mental health services. Participants will be randomised to receive either a novel, targeted, youth-focussed sleep intervention in addition to usual care or usual care alone. Assessor-blinded assessments will be conducted at baseline, 3 months (post-intervention) and 9 months (follow-up). The eight-session psychological intervention will target the key mechanisms which disrupt sleep: circadian rhythm irregularities, low sleep pressure, and hyperarousal. To gain an in-depth understanding of participants’ views on the acceptability of the intervention and study procedures, 16 participants (n=10 intervention, n=6 control) will take part in qualitative interviews. Analyses will focus on feasibility outcomes (recruitment, retention, and treatment uptake rates) and provide initial CI estimates of intervention effects. Thematic analysis of the qualitative interviews will assess the acceptability of the intervention and trial procedures.Ethics and dissemination The trial has received ethical approval from the NHS Health Research Authority. Findings will be disseminated through peer-reviewed publications, conference presentations, and lay networks.Trial registration number ISRCTN85601537.

Abstract Background Evaluation of integrated care programmes for individuals with multi-morbidity requires a broader evaluation framework and a broader definition of added value than is common in cost-utility analysis. This is possible through the use of Multi-Criteria Decision Analysis (MCDA). Methods and results This paper presents the seven steps of an MCDA to evaluate 17 different integrated care programmes for individuals with multi-morbidity in 8 European countries participating in the 4-year, EU-funded SELFIE project. In step one, qualitative research was undertaken to better understand the decision-context of these programmes. The programmes faced decisions related to their sustainability in terms of reimbursement, continuation, extension, and/or wider implementation. In step two, a uniform set of decision criteria was defined in terms of outcomes measured across the 17 programmes: physical functioning, psychological well-being, social relationships and participation, enjoyment of life, resilience, person-centeredness, continuity of care, and total health and social care costs. These were supplemented by programme-type specific outcomes. Step three presents the quasi-experimental studies designed to measure the performance of the programmes on the decision criteria. Step four gives details of the methods (Discrete Choice Experiment, Swing Weighting) to determine the relative importance of the decision criteria among five stakeholder groups per country. An example in step five illustrates the value-based method of MCDA by which the performance of the programmes on each decision criterion is combined with the weight of the respective criterion to derive an overall value score. Step six describes how we deal with uncertainty and introduces the Conditional Multi-Attribute Acceptability Curve. Step seven addresses the interpretation of results in stakeholder workshops. Discussion By discussing our solutions to the challenges involved in creating a uniform MCDA approach for the evaluation of different programmes, this paper provides guidance to future evaluations and stimulates debate on how to evaluate integrated care for multi-morbidity.

BackgroundSleep problems are pervasive in people with schizophrenia, but there are no clinical guidelines for their treatment. The Better Sleep Trial (BEST) concluded that suitably adapted cognitive–behavioural therapy (CBT) is likely to be highly effective, although its cost-effectiveness is unknown.AimsTo assess the potential cost-effectiveness of CBT for sleep disorders in patients with schizophrenia.MethodAn economic evaluation of the BEST study with a 6-month time horizon was used to establish the cost-effectiveness of CBT plus usual care in terms of costs per quality-adjusted life year (QALY) gained. Uncertainty was displayed on cost-effectiveness planes and acceptability curves. Value of information analysis was performed to estimate the benefits of obtaining further evidence.ResultsOn average, the treatment led to a 0.035 QALY gain (95% CI −0.016 to 0.084), and £1524 (95% CI −10 529 to 4736) and £1227 (95% CI −10 395 to 5361) lower costs from National Health Service and societal perspectives, respectively. The estimated value of collecting more information about the effects of the CBT on costs and QALYs was approximately £87 million.ConclusionsCBT for insomnia in people with schizophrenia is effective and potentially cost-effective. A larger trial is needed to provide clear evidence about its cost-effectiveness.RelevancePatients with schizophrenia have multiple complex health needs, as well as very high rates of depression, suicidal ideation and poor physical health. The results of this study showed that treating pervasive sleep problems in this patient group with cognitive–behavioural therapy (CBT) is very likely to improve patient quality of life in the short term. Clinicians most commonly use hypnotic medication to treat sleeping disorders. This study indicates that CBT may be an effective and cost-effective intervention in this patient group. This alternative would also be aligned with patient preferences for psychological and behavioural-type therapy.Declaration of interestNone.

Summary: Background: Calls for increased funding for mental health services require many lines of evidence in support, including estimates of economic impact. One understudied source of cost is violence perpetrated by individuals with severe mental illness. Estimating this economic impact can inform budget planning across several government sectors and emphasise the importance of violence prevention. Therefore, we aimed to provide a comprehensive estimate of the economic costs of violence perpetrated by people with severe mental illness. Methods: For this retrospective analysis, we used a prevalence-based modelling approach to estimate the annual economic cost of violent incidents committed by people with severe mental illness in England and Wales during 2015–16. The model was based on secondary data, including the association between violence and severe mental illness, illness prevalence, recidivism, absolute numbers of violent incidents in 2015–16, and costs to society per violent crime, by area of spending. Uncertainty was addressed with probabilistic and deterministic sensitivity analyses that tested the effect of underreporting of domestic violence and distributions of crime types in individuals with severe mental illness. Outcomes: The estimated annual economic impact of violence perpetrated by people with severe mental illness was £2·5 (95% CI 1·4–4·5) billion in England and Wales in 2015–16, or 5·3% of the total estimated societal cost of violence. The largest contributors to the cost of violent crime perpetrated by individuals with severe mental illness were the cost of physical and emotional harm to victims (£1·4 [95% CI 0·8–2·5] billion), followed by lost productivity of victims (£348.0 [190·0–628·8] million), while the combined cost to the police and criminal justice system was £561·3 (305·9–1009·2) million and the cost to health services was £136·7 [74·3–246·3] million. The additional cost to secure forensic care was estimated to be £487·7 (302·0–709·1) million. Interpretation: The economic impact of violence perpetrated by individuals with severe mental illness is potentially important. Preventing violence, especially through services for individuals with comorbid substance misuse, and reducing recidivism might lead to cost savings at a governmental and individual level, in addition to the clinical and societal benefits. Funding: Wellcome Trust, National Institute for Health Research (NIHR) Oxford Biomedical Research Centre, and NIHR Applied Research Collaboration Oxford and Thames Valley.

Objective To evaluate the impact of child and adolescent mental health services (CAMHS) transformation in South East England on patient access, resource utilisation and health outcomes.Design In an observational study, we use difference-in-differences analysis with propensity score matching to analyse routinely collected patient level data.Setting Three CAMHS services in South East England.Participants All patients attending CAMHS between April 2012 and December 2018, with more than 57 000 spells of care included.Main outcome measures The rate and volume of people accessing CAMHS; waiting times to the first contact and waiting times between the first and second contact; and health outcomes, including the Strengths and Difficulties Questionnaire (SDQ) and the Revised Child Anxiety and Depression Scale (RCADS).Results The intervention led to 20% (incidence rate ratio: 1.20; 95% CI: 1.15 to 1.24) more new patients starting per month. There was mixed evidence on waiting times for the first contact. The intervention led to 10% (incidence rate ratio: 1.10; 95% CI: 1.02 to 1.18) higher waiting time for the second contact. The number of contacts per spell (OR: 1.08; 95% CI: 0.94 to 1.25) and the rereferral rate (OR: 1.06; 95% CI: 0.96 to 1.17) were not significantly different. During the post intervention period, patients in the intervention group scored on average 3.3 (95% CI: −5.0 to −1.6) points lower on the RCADS and 1.0 (95% CI: −1.8 to -0.3) points lower on the SDQ compared with the control group after adjusting for the baseline score.Conclusions Overall, there are signs that transformation can help CAMHS achieve the objectives of greater access and improved health outcomes, but trade-offs exist among different performance metrics, particularly between access and waiting times. Commissioners and providers should be conscious of any trade-offs when undertaking service redesign and transformation.

Introduction Neonatal mortality is an urgent policy priority to improve global population health and reduce health inequality. As health systems in Kenya and elsewhere seek to tackle increased neonatal mortality by improving the quality of care, one option is to train and employ neonatal healthcare assistants (NHCAs) to support professional nurses by taking up low-skill tasks.Methods Monte-Carlo simulation was performed to estimate the potential impact of introducing NHCAs in neonatal nursing care in four public hospitals in Nairobi on effectively treated newborns and staff costs over a period of 10 years. The simulation was informed by data from 3 workshops with >10 stakeholders each, hospital records and scientific literature. Two univariate sensitivity analyses were performed to further address uncertainty.Results Stakeholders perceived that 49% of a nurse full-time equivalent could be safely delegated to NHCAs in standard care, 31% in intermediate care and 20% in intensive care. A skill-mix with nurses and NHCAs would require ~2.6 billionKenyan Shillings (KES) (US$26 million) to provide quality care to 58% of all newborns in need (ie, current level of coverage in Nairobi) over a period of 10 years. This skill-mix configuration would require ~6 billion KES (US$61 million) to provide quality of care to almost all newborns in need over 10 years.Conclusion Changing skill-mix in hospital care by introducing NHCAs may be an affordable way to reduce neonatal mortality in low/middle-income countries. This option should be considered in ongoing policy discussions and supported by further evidence.

Introduction: The aim of this review is to systematically assess the methodological quality of economic evaluations in integrated care and to identify challenges with conducting such studies. Theory and methods: Searches of grey-literature and scientific papers were performed, from January 2000 to December 2018. A checklist was developed to assess the quality of economic evaluations. Authors’ statements of challenges encountered during their evaluations were qualitatively coded. Results: Forty-four articles were eligible for inclusion. The review found that study design, measurement of cost and outcomes, statistical analysis and presentation of data were the areas with most quality variation. Authors identified challenges mostly related to time horizon of the evaluation, inadequate or lack of comparator group, contamination bias, and a post-hoc evaluation culture. Discussion: Our review found significant differences in quality, with some studies showing poor methodological rigor; challenging conclusions on the cost-effectiveness of integrated care. Conclusion: It is essential for evaluators to use best-practice standards when planning and conducting economic evaluations, in order to build a reliable evidence base for decision-making in integrated care.

Background: The Comprehensive Geriatric Assessment (CGA) is a multidisciplinary process that determines a frail older person’s medical, functional, psychological and social capability to ensure that they have a co-ordinated plan for treatment and follow-up. Objectives: To improve our understanding of the effectiveness, cost-effectiveness and implementation of the CGA across hospital and hospital-at-home settings. Methods: We used a variety of methods. We updated a Cochrane review of randomised trials of the CGA in hospital for older people aged ≥ 65 years, conducted a national survey of community CGA, analysed data from three health boards using propensity score matching (PSM) and regression analysis, conducted a qualitative study and used a modified Delphi method. Results: We included 29 trials recruiting 13,766 participants in the Cochrane review of the CGA. Older people admitted to hospital who receive the CGA are more likely to be living at home at 3–12 months’ follow-up [relative risk (RR) 1.06, 95% confidence interval (CI) 1.01 to 1.10] (high certainty). The probability that the CGA would be cost-effective at a £20,000 ceiling ratio for quality-adjusted life-years (QALYs), life-years (LYs) and LYs living at home was 0.50, 0.89, and 0.47, respectively (low-certainty evidence). After PSM and regression analysis comparing CGA hospital with CGA hospital at home, we found that the health-care cost (from admission to 6 months after discharge) in site 1 was lower in hospital at home (ratio of means 0.82, 95% CI 0.76 to 0.89), in site 2 there was little difference (ratio of means 1.00, 95% CI 0.92 to 1.09) and in site 3 it was higher (ratio of means 1.15, 95% CI 0.99 to 1.33). Six months after discharge (excluding the index admission), the ratio of means cost in site 1 was 1.27 (95% CI 1.14 to 1.41), in site 2 was 1.09 (95% CI 0.95 to 1.24) and in site 3 was 1.70 (95% CI 1.40 to 2.07). At 6 months’ follow-up (excluding the index admission), there may be an increased risk of mortality (adjusted) in the three hospital-at-home cohorts (site 1: RR 1.09, 95% CI 1.00 to 1.19; site 2: RR 1.29, 95% CI 1.15 to 1.44; site 3: RR 1.27, 95% CI 1.06 to 1.54). The qualitative research indicates the importance of relational aspects of health care, incorporating caregivers’ knowledge in care planning, and a lack of clarity about the end of an episode of health care. Core components that should be included in CGA focus on functional, physical and mental well-being, medication review and a caregiver’s ability to care. Limitations: The risk of residual confounding limits the certainty of the findings from the PSM analysis; a second major limitation is that the research plan did not include an investigation of social care or primary care. Conclusions: The CGA is an effective way to organise health care for older people in hospital and may lead to a small increase in costs. There may be an increase in cost and the risk of mortality in the population who received the CGA hospital at home compared with those who received the CGA in hospital; randomised evidence is required to confirm or refute this. Caregiver involvement in the CGA process could be strengthened. Funding: The National Institute for Health Research Health Services and Delivery Research programme.

Health economists are increasingly interested in integrated care in order to support decision-makers to find cost-effective solutions able to tackle the threat that chronic diseases pose on population health and health and social care budgets. However, economic evaluation in integrated care is still in its early years, facing several difficulties. The aim of this paper is to describe the unique nature of integrated care as a topic for economic evaluation, explore the obstacles to perform economic evaluation, discuss methods and techniques that can be used to address them, and set the basis to develop a research agenda for health economics in integrated care. The paper joins the voices that call health economists to pay more attention to integrated care and argues that there should be no more time wasted for doing it.

Background: Falling participation by young women in cervical screening has been observed at a time that has seen an increase in the incidence of cervical cancer in the UK in women aged 90%. Conclusion: Women receiving their initial screening invitation frequently delay taking up the offer and the net impact of interventions was small. Timed appointments and SSKs sent to non-attenders at 6 months are likely to be a cost-effective means of increasing uptake and should be considered further. HPV vaccination in the catch-up programme was associated with an increased uptake of cervical screening. Future work should focus on optimising self-sampling in terms of age range, timing of offer for non-attenders and use of urine testing instead of vaginal samples. Trial registration: Current Controlled Trials ISRCTN52303479. Funding: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 68. See the NIHR Journals Library website for further project information.

Introduction The size and composition of the European Union healthcare workforce are key drivers of expenditure and performance; it now includes new health professions and enhanced roles for established professions. This project will systematically analyse how this has contributed to health service redesign, integration and performance in 9 European countries (Scotland, England, Netherlands, Germany, Italy, Czech Republic, Poland, Norway, and Turkeyi). This paper describes the protocol for collection of survey data in 3 distinct care pathways, and sets it in the context of the wider programme.Methods Questionnaires will be distributed to healthcare professionals (n=14 580), managers (n=3564) and patients (n=19 440) in 3 care pathways (breast cancer; type 2 diabetes; and coronary heart disease) within 12 hospitals and associated primary care settings in each country. Questionnaire topics will include demography, the different professionals working on the care pathway, the tasks they do and the time taken, their decision-making abilities when considering skill mix, specialisation and integration of care. Patient satisfaction, healthcare utilisation and preferences will be explored. In later work, register data and data from patient records will be used to record clinical outcomes. Data will also be collected on workforce and procedure costs. Descriptive analysis will identify the different models of care and multivariate analysis will establish the most clinically and cost-effective models.Ethics and dissemination This protocol was approved by ethical committees in each country. Findings will be disseminated through national/international clinical, health services research and health workforce conferences, and publications in national/international peer-reviewed journals.

The health, social and economic impact of chronic diseases is well documented in Europe. However, chronic diseases threaten relatively more the ‘memorandum and peripheral’ Eurozone countries (i.e., Greece, Spain, Portugal and Ireland), which were under heavy recession after the economic crisis in 2009. Especially in Greece, where the crisis was the most severe across Europe, the austerity measures affected mainly people with chronic diseases. As a result, the urgency to tackle the threat of chronic diseases in Greece by promoting public health and providing effective chronic care while flattening the rising health care expenditure is eminent. In many European countries, integrated care is seen as a means to achieve this.The aim of this paper was to support Greek health policy makers to develop an action plan from 2015 onwards, to integrate care by bridging local policy context and needs with knowledge and experience from other European countries. To achieve this aim, we adopted a conceptual framework developed by the World Health Organization on one hand to analyse the status of integrated care in Greece, and on the other to develop an action plan for reform. The action plan was based on an analysis of the Greek health care system regarding prerequisite conditions to integrate care, a clear understanding of its context and successful examples of integrated care from other European countries. This study showed that chronic diseases are poorly addressed in Greece and integrated care is in embryonic stage.Greek policy makers have to realise that this is the opportunity to make substantial reforms in chronic care. Failing to reform towards integrated care would lead to the significant risk of collapse of the Greek health care system with all associated negative consequences. The action plan provided in this paper could support policy makers to make the first serious step to face this challenge. The details and specifications of the action plan can only be decided by Greek policy makers in close cooperation with other health and social care partners. This is the appropriate time for doing so.

Chronic diseases have an increasingly negative impact on (1) population health by increasing morbidity and mortality, (2) society by increasing health inequalities and burden to informal caregivers, and (3) economy by requiring enormous financial resources and jeopardising macro-economic development (e.g. consumption, capital accumulation, labour productivity and labour supply). Integrated care is the most promising concept in redesigning care to tackle the increasing threat of chronic diseases. Several European countries have experimented with models for integrating care, most frequently in the form of disease management programmes. These models were often supported by payment schemes to provide financial incentives to health care providers for implementing integrated care. This thesis aimed to investigate these payment schemes and assess their impact, explore the variability in costs of disease management programmes, and determine the costs and effects of disease management programmes.

Background: Disease management programmes are increasingly used to improve the efficacy and effectiveness of chronic care delivery.But, disease management programme development and implementation is a complex undertaking that requires effective decision-making.Choices made in the earliest phases of programme development are crucial, as they ultimately impact costs, outcomes and sustainability. Methods: To increase our understanding of the choices that primary healthcare practices face when implementing such programmes and to stimulate successful implementation and sustainability, we compared the early implementation of eight cardiovascular disease management programmes initiated and managed by healthcare practices in various regions of the Netherlands. Using a mixed-methods design, we identified differences in and challenges to programme implementation in terms of context, patient characteristics, disease management level, healthcare utilisation costs, development costs and health-related quality of life. Results: Shifting to a multidisciplinary, patient-centred care pathway approach to disease management is demanding for organisations, professionals and patients, and is especially vulnerable when sustainable change is the goal. Funding is an important barrier to sustainable implementation of cardiovascular disease management programmes, although development costs of the individual programmes varied considerably in relation to the length of the development period. The large number of professionals involved in combination with duration of programme development was the largest cost drivers. While Information and Communication Technology systems to support the new care pathways did not directly contribute to higher costs, delays in implementation indirectly did. Conclusions: Developing and implementing cardiovascular disease management programmes is time-consuming and challenging. Multidisciplinary, patient-centred care demands multifaceted changes in routine care. As care pathways become more complex, they also become more expensive. Better preparedness and training can prevent unnecessary delays during the implementation period and are crucial to reducing costs.